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Trial record 6 of 47 for:    necrotizing enterocolitis | NIH

Metronidazole Pharmacokinetics (PK) in Premature Infants (PTN_METRO)

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ClinicalTrials.gov Identifier: NCT01222585
Recruitment Status : Completed
First Posted : October 18, 2010
Results First Posted : December 18, 2013
Last Update Posted : February 6, 2014
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The EMMES Corporation
Information provided by (Responsible Party):
Michael Cohen-Wolkowiez, Duke University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Serious Systemic Infections
Necrotizing Enterocolitis
Intervention: Drug: Metronidazole

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Metronidazole IV Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours

Participant Flow:   Overall Study
    Metronidazole IV
STARTED   24 
COMPLETED   24 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Treatment Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours

Baseline Measures
   Treatment 
Overall Participants Analyzed 
[Units: Participants]
 24 
Age [1] 
[Units: Days]
Median (Full Range)
 27 
 (1 to 82) 
[1] Post Natal Age (Days)
Age [1] 
[Units: Weeks]
Mean (Full Range)
 25 
 (23 to 31) 
[1] Gestational age (weeks)
Gender 
[Units: Participants]
 
Female   16 
Male   8 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   6 
Not Hispanic or Latino   18 
Unknown or Not Reported   0 
Race (NIH/OMB) 
[Units: Participant]
 
American Indian or Alaska Native   0 
Asian   0 
Native Hawaiian or Other Pacific Islander   1 
Black or African American   7 
White   16 
More than one race   0 
Unknown or Not Reported   0 
Region of Enrollment 
[Units: Participants]
 
United States   24 
Birth Weight 
[Units: Grams]
Median (Full Range)
 740 
 (431 to 1466) 


  Outcome Measures

1.  Primary:   Area Under the Curve at Steady State   [ Time Frame: pre-dose: 30 min; post-dose:10 min, 3-4,6-8, 12-13, 24-25, 36-37, 48-49, 72-73 hours post dose ]

2.  Primary:   Loading Dose Maximum Concentration   [ Time Frame: 2-5 days of study drug administration ]

3.  Primary:   Loading Dose Minimum Concentration   [ Time Frame: 2-5 days of study drug administration ]

4.  Primary:   Multiple Dose Maximum Concentration   [ Time Frame: 2-5 days of study drug administration ]

5.  Primary:   Multiple Dose Minimum Concentration   [ Time Frame: 2-5 days of study drug administration ]

6.  Primary:   Clearance   [ Time Frame: 2-5 days of study drug administration ]

7.  Primary:   Volume of Distribution   [ Time Frame: 2-5 days of study drug administration ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Michael Cohen-Wolkowiez, MD
Organization: Duke Clinical Research Institute
phone: 919668-8812
e-mail: michael.cohenwolkowiez@dm.duke.edu


Publications of Results:

Responsible Party: Michael Cohen-Wolkowiez, Duke University
ClinicalTrials.gov Identifier: NCT01222585     History of Changes
Other Study ID Numbers: Pro00024571
HHSN27500003I ( Other Grant/Funding Number: NICHD )
First Submitted: October 6, 2010
First Posted: October 18, 2010
Results First Submitted: July 23, 2013
Results First Posted: December 18, 2013
Last Update Posted: February 6, 2014